1. Field of the Invention
The present invention relates in general to a system and method in the field of prolapse treatment. More particularly, the present invention relates to an apparatus with multiple components, and a method for surgically correcting tissue wall prolapse using the same. Specifically, one embodiment of the present invention is a kit that has a pre-cut shaped mesh graft, and a graft delivery device.
2. Discussion of the Related Art
As is known to those skilled in the art, the treatment of vaginal wall prolapse has been hampered by high failure rates. Reasons for failure include the inherent weakness of the tissue being re-approximated and the inability of the repair to withstand the forces applied by the abdominal cavity bearing down from above. In the last decade, one advance in repair has been the addition of grafts to reinforce vaginal prolapse repairs. While this technique has gained acceptance, there lacks a consensus regarding how to affix the graft under the vaginal wall to best maintain durability and vaginal caliber.
Some known procedures can cause patient discomfort and/or pain and there is a risk that the graft will become dislodged with time. Additionally, when a graft is sewn into place with standard sutures over the pelvic floor muscles, it may cause pain from suture entrapment. Further, sutures are prone to pullout because the sutures are placed into tissue that is thin and inherently weak. Finally, the placement of the sutures varies among surgeons. Accordingly, it is difficult to teach proper graft placement.
With the introduction of new techniques, improved devices have been made commercially available. In general, these systems utilize medical mesh with wings at the corners so that the mesh may be drawn through the pelvic floor musculature and pelvic ligaments to secure the mesh.
An accepted access point for securing the wings of these systems has been through the obturator membrane and ischiorectal fossa. Access is generally made via these structures because the apex of the vagina is located deep within the pelvis. However, the problem with accessing the apex via these structures is that this anatomy is unfamiliar to surgeons. Further, safety remains a concern for surgeons because these systems require the passage of sharp needles long distances through these unfamiliar anatomic paths with unseen neurovascular structures potentially nearby. Thus, extensive training and anatomy education is required to properly learn the technique.
In general, the embodiments disclosed in the above-referenced patents and publications have the disadvantage that they are difficult or dangerous to use without extensive training. Also, they are only partially effective to treat prolapse. Other disadvantages include increased risk and ineffective results over time. Given these disadvantages, patients suffering prolapse either must wait long periods of time for treatment or forego treatment altogether because of the risk involved and the necessary high-level of surgeon skill. This further leads to a procedure with a relatively high cost.
Therefore, what is needed is a relatively simple apparatus and method for the treatment of vaginal wall prolapse. Specifically, what is needed is an apparatus and method that reduce patient discomfort and that are easily repeatable and highly effective over time.